Notable regulatory approvals of emerging technologies over the past 30 days

Along with AI in its various iterations, the list may include virtual and augmented reality, 3D printing and visualization, robotics and other innovative technologies changing healthcare delivery.

Nanowear: FDA clearance for AI diagnostics and monitoring via wearable nanosensor platform (Sept. 28)

Wyss Center: CE mark certification for longitudinal, AI-preparatory brain visualization cloud software (Sept. 29)

Siemens: FDA clearance for photon-counting CT detectors. Hailed by the agency as “the first new major technological improvement for computed tomography imaging in nearly a decade” (Sept. 30)

IotaMotion: FDA de novo classification for robotic-assisted cochlear implant insertion system (Oct. 5)

Amber Implants: FDA breakthrough device designation for 3D-printed spinal implant system (Oct. 5)

SyncThink: FDA clearance for AI analysis of eye movement in mobile concussion diagnostics (Oct. 5)

DreaMed: Expanded FDA clearance for AI-guided insulin administration (Oct. 6)

Medtronic: CE mark certification for robotic-assisted surgery system (Oct. 11)

Delphinus: FDA premarket approval for 3D breast ultrasound tomography (Oct. 12)

Subtle Medical: Health Canada approval for AI enhancement of MRI and PET imaging (Oct. 13)

Cognetivity Neurosciences: FDA approval for AI-aided rapid dementia assessment (Oct. 20)

Panakeia: CE mark certification for AI breast cancer image analysis (Oct. 21)

Naviswiss: FDA clearance for digital hip replacement surgery planning (Oct. 21)

Around the web

The Department of Defense is gifting Case Western researchers a grant to study the use of AI in determining whether patients require surgery. 

This study brings light to the prospect of a "fully automated solution" for echocardiogram analysis, experts reported.

Experts noted a "significant" reduction in false positives and false negatives using their modified machine learning model.

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